A new European Union regulation will no longer recognise medical device quality certificates obtained in Switzerland. It is feared that some Swiss manufacturers of medical devices will face additional barriers to export their products to the EU from May.
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On Tuesday, the Swiss Association for Quality and Management Systems (SQS) sounded the alarm on the change in status quo that will adversely affect the industry. The new European Medical Device Regulation (MDR) will oblige Swiss companies active in the medical technology sector to certify their products according to the new requirements from May 26 onwards.
SQS, an international certification body, says it has incorporated the MDR into its certification process but considers this solution to be insufficient. Small companies and start-ups often do not have the resources to get certified in the EU.
The issue is complicated by fractious negotiations between Switzerland and the EU on establishing an updated set of framework conditions to govern future relations. The slow pace of negotiations means that Switzerland risks being treated as a “third country” in the medical technology sector. Its manufacturers would then have to meet more stringent and expensive requirements to meet EU safety and quality standards.
The new EU regulation should have entered into force on May 26, 2020. But it was delayed by a year because there were too few accreditation bodies capable of certifying products according to the new rules.
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